Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Soft Tissue Open Surgeries
Public ClinicalTrials.gov record NCT01731938. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Single-blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis During Soft Tissue Open Surgeries
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is designed to assess the safety and efficacy of fibrin sealant (FS) Grifols in patients undergoing elective (non-emergency) soft tissue open surgery where bleeding may be present. The purpose of this study is to demonstrate that FS Grifols is not inferior to commercially-available oxidized cellulose pads (Surgicel®) in providing benefit in the time to hemostasis (i.e, the stoppage of bleeding). This study has a Preliminary Part (I) for study teams to become familiar with the application of FS Grifols and a Primary Part (II) to assess the safety and efficacy of FS Grifols. In both parts of the study, patients will be randomized in a 1:1 ratio to either FS Grifols or Surgicel.
Study identification
- NCT ID
- NCT01731938
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 327 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2012
- Primary completion
- Mar 31, 2015
- Completion
- May 31, 2015
- Last update posted
- Feb 22, 2017
2012 – 2015
United States locations
- U.S. sites
- 17
- U.S. states
- 13
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 407 | Florence | Alabama | 35630 | — |
| 320, 322, 323 | Pasadena | California | 91105 | — |
| 404 | Bridgeport | Connecticut | 06606 | — |
| 321 | Boynton Beach | Florida | 33472 | — |
| 312 | Rochester | Minnesota | 55905 | — |
| 300 | St Louis | Missouri | 63110 | — |
| 327 | Albany | New York | 12208 | — |
| 305 | New York | New York | 10016 | — |
| 332 | Poughkeepsie | New York | 12601 | — |
| 304 | Winston-Salem | North Carolina | 27157 | — |
| 307 | Pittsburgh | Pennsylvania | 15224 | — |
| 325 | Charleston | South Carolina | 29425 | — |
| 331 | Chattanooga | Tennessee | 37403 | — |
| 314 | Memphis | Tennessee | 38613 | — |
| 402 | Houston | Texas | 77024 | — |
| 316 | Houston | Texas | 77030 | — |
| 405 | Tacoma | Washington | 98431 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01731938, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 22, 2017 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01731938 live on ClinicalTrials.gov.